Ordering Rules - Mpje

1. What is the required record retention period for executed DEA Form 222 (or CSOS records)?

   Keep for 2 years (federal minimum). Federal law requires retention of these records for at least 2 years to support audits and investigations.

2. Who is permitted to sign a paper DEA Form 222 for a registrant?

   Registrant or a DEA-authorized Power of Attorney (POA). Only authorized signers can execute Form 222 to maintain security and legal responsibility for Schedule II orders.

3. What is required for a registrant to use CSOS to order Schedule II controlled substances?

   A valid CSOS digital certificate for the registrant/POA agent. A digital certificate verifies identity and enables secure electronic ordering equivalent to Form 222.

4. What is the rule for how many different controlled substances may be listed on one DEA Form 222?

   Multiple Schedule II drugs allowed, within line limits. Regulations allow multiple Schedule II items on one form to facilitate efficient ordering, subject to the 10-line maximum.

5. What is the purpose of the purchaser's copy of a paper DEA Form 222 after ordering is complete?

   It serves as the executed order record for the buyer. The purchaser's copy documents the transaction details for recordkeeping and verification of Schedule II receipts.

6. What is the rule for storing executed DEA Form 222 records relative to other controlled substance records?

   Maintain separately or readily retrievable from other records. Separate or retrievable storage facilitates efficient inspections and compliance with DEA recordkeeping rules.

7. What identifying information must be included for each Schedule II item on DEA Form 222?

   Drug name, strength, dosage form, and package size. Detailed product information ensures accurate identification and prevents errors in Schedule II orders under DEA requirements.

8. What is required to revoke a Power of Attorney for signing DEA Form 222?

   Written revocation by registrant; keep with POA records. Written revocation ensures clear termination of authority, with records maintained for audit and compliance purposes.

9. What is the rule for partial filling of a Schedule II order by a supplier on a DEA Form 222?

   Supplier may partially fill; must document shipped quantity/date. Partial fills accommodate supply issues, with annotations ensuring accurate tracking of Schedule II distributions.

10. What is the correct DEA form used to order Schedule II controlled substances?

    DEA Form 222 (or CSOS electronic order). Federal regulations mandate DEA Form 222 or CSOS for secure ordering and tracking of Schedule II controlled substances between registrants.

11. Identify the ordering error: A paper DEA Form 222 lists 12 separate Schedule II line items.

    Exceeds the 10 line-item maximum per form. The form's design restricts to 10 lines to standardize and control the volume of Schedule II orders.

12. Identify the correct ordering method: A pharmacy needs to order alprazolam (C-IV) from its wholesaler.

    Standard invoice/purchase order (DEA Form 222 not required). Schedule IV drugs do not require special forms, allowing standard ordering methods like noncontrolled substances.

13. What is the key legal requirement regarding alterations or erasures on a paper DEA Form 222?

    No alterations/erasures; prepare a new form if incorrect. Prohibiting changes prevents fraud and maintains the integrity of Schedule II order documentation.

14. Which schedules may be ordered using a standard invoice/purchase order (no DEA Form 222 required)?

    Schedules III–V (and noncontrolled drugs). Schedules III-V are treated like noncontrolled drugs for ordering, without the need for special DEA forms under federal rules.

15. Which schedules of controlled substances require DEA Form 222 or CSOS to be ordered?

    Schedule II only. DEA requires Form 222 or CSOS exclusively for Schedule II to prevent diversion and ensure accountability in distribution.

16. What is the maximum number of line items allowed on a single paper DEA Form 222?

    Up to 10 line items. The paper DEA Form 222 is designed with exactly 10 lines to limit and organize orders of Schedule II substances.

17. Identify the ordering error: A pharmacy lets a technician sign DEA Form 222 with no POA on file.

    Only registrant or POA agent may sign DEA Form 222. Signing without authorization violates DEA rules on who can execute controlled substance orders.

18. What is the legal status of ordering Schedule II drugs by telephone from a wholesaler without CSOS or Form 222?

    Not permitted; must use CSOS or executed DEA Form 222. Telephone orders lack formal documentation and security, breaching requirements for Schedule II substances.

19. What DEA ordering method is permitted instead of a paper DEA Form 222 for Schedule II drugs?

    CSOS (Controlled Substances Ordering System). CSOS provides a secure electronic alternative to paper Form 222, allowing digital signatures and orders for Schedule II substances.

20. What must exist before an employee may sign DEA Form 222 as an agent for the registrant?

    A valid written Power of Attorney on file. A POA delegates signing authority, ensuring compliance while allowing agents to act on behalf of the registrant.

21. What quantity information must be entered for each line item on a paper DEA Form 222?

    Number of packages (and package size). Specifying packages and size provides precise quantity details for accountability in Schedule II transactions.

22. What must the supplier do on DEA Form 222 when an item is not shipped (unaccepted line item)?

    Mark the item as not accepted/canceled per supplier procedures. Marking unshipped items maintains accurate records and prevents discrepancies in Schedule II order fulfillment.

23. Identify the ordering error: A pharmacy orders oxycodone (C-II) using a normal wholesaler invoice only.

    Schedule II must be ordered via DEA Form 222 or CSOS. Normal invoices lack the security features required for Schedule II, violating DEA ordering mandates.

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